The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Gamma Knife Perfexion, Model 715000.
| Device ID | K061941 |
| 510k Number | K061941 |
| Device Name: | LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm, SE S-103 93 |
| Contact | Peter Lowendahl |
| Correspondent | Peter Lowendahl ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm, SE S-103 93 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-10 |
| Decision Date | 2006-08-21 |
| Summary: | summary |